Company: University Hospitals of Cleveland
Product: Blood products
Date: 8/19/02
With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining were taken with this particular phlebotomist.
FDA District: Cincinnati District Office
